FDA BRIEF: Week of November 7, 2016
The Race to bring Penicillin to the Troops in WWII
By: John P. Swann, Ph.D., FDA Historian
75 years ago..
FDA, academic, commercial, nonprofit, and governmental institutions raced to provide penicillin to WWII troops
- Difficult to purify, scale up
- US and Britain developed production modifications to increase yield by 100 fold
- FDA technicians certified potency, absence of fever-producing contaminants, toxicity, sterility, and optimum moisture for stability
- Participating firms increased purity and production for civilian needs as well
- External part (behind the ear) + internal part (surgically placed under skin)
- Magnet holds external system in place next to the implanted internal system
- Receives sound, processes it, sends small electric currents to auditory nerve which signals brain
- Can use as early as 18 m0.
FDA Regulation : Designated as Class III devices
Future: Sophisticated technologies to minimize background noise, increase the noise-to-sound ratio, pairing with another cochlear implant or a hearing aid in other ear.